On October 26, 2002 the Medical Device User Fee and Modernization
Act of 2002 signed into law. This law authorizes FDA to charge a
fee for medical device Premarket Notifcation 510(k) reviews. This
application fee applies to most 510(k)'s including Traditional,
Abbreviated, and Special 510(k)s, but not those exempted or waived
as noted below. Small businesses may qualify for a reduced fee beginning
in FY 2004. Payment must be received on or before the time the 510(k)
submission is submitted. If the submitter has not paid all fees
owed, FDA will consider the submission incomplete and will not accept
it for filing.
The applicable fee corresponds with the date of receipt of the
submission by FDA. Please note that FDA will consider the 510(k)
submission incomplete and will not accept it for filing until the
fee is paid in full. That is, the date of receipt is the date that
the submission has been received AND the fee is paid in full.
FDA will adjust these fees each year to account for inflation,
changes in workloads, and other factors. The small business fee
will be 80% of the standard fee for FY 2004 and subsequent fiscal
years. FDA will announce the new fees for the next fiscal year in
a Federal Register notice by August 1 of each year.
Exemptions and Waivers
The following exemptions or waivers apply:
Fee Exemptions and Waivers (No Fee
for These)
Category
Exemption or Waiver
Third-party 510(k)
Exempt from any FDA fee; however, the third-party
does charge a fee for its review.
Any application for a device intended solely
for pediatric use.
Exempt from user fee. Please note that changing
the intended use from pediatric use to adult use requires the
submission of a new 510(k). The new 510(k) is subject to the
510(k) review fee at the time of submission.
Any application from a State or Federal Government
entity.
Exempt from any fee unless the device is to be
distributed commercially.
When to Pay
Payment must be received at or before the time the 510(k) submission
is submitted. If the submitter has not paid all fees owed, FDA will
consider the submission incomplete and will not accept it for filing.
How/Where to Send Payment
The review fee may be submitted by mail, courier, or wire transfer.
The applicant must first complete the Medical Device
User Fee Cover Sheet (Form FDA 3601) online. The Medical
Device User Fee Cover Sheet and instructions are available at:
http://www.fda.gov/oc/mdufma/coversheet.html
Follow the on-line instructions for completing your cover sheet.
When you have provided the necessary information, click the button
labeled "Transmit Cover Sheet to FDA and Continue." When you transmit
your information to FDA, the system will generate a printable
copy of your cover sheet. Print two copies for FDA use, and any
number of copies for your own use.
Send a printed copy of your cover sheet with your original 510(k)
submission.
Send a printed copy of your cover sheet with your payment. Be
sure to include the Payment Identification Number (from your cover
sheet) on your check, bank draft, or U.S. Postal Money Order.
Send your payment to:
By Mail:
Food and Drug Administration
P.O. Box 956733
St. Louis, MO 63195-6733
By Courier:
If the check is sent by a courier, the courier may deliver
the checks to:
US Bank
Attn: Government Lockbox 956733
1005 Convention Plaza
St. Louis, MO 63101
(Note: This address is for courier delivery only.
Contact the US Bank at (314) 418-4983 if you have any
questions concerning courier delivery.)
Additional information, including how to submit payment by wire
transfer, can be found in MDUFMA
Fee Payment Instructions. Please note that the bank or financial
institution usually assess a fee for sending a wire transfer. The
applicant is responsible for paying all wire transfer fees. FDA
will not pay any of these fees.
If needed for accounting purposes, FDA's tax identification number
is 53-0196965.
Fees should arrive at the bank at least 1 day before the application
arrives at FDA. FDA recommends that you send the payment to the
bank 4-5 business days before the application arrives at FDA so
there is no delay in starting the review of your application. FDA
records as the application receipt date the latter of the following:
The date the submission was received by FDA; or
The date US Bank notifies FDA that payment has been received.
US Bank is required to notify FDA within 1-working day, using the
Payment Identification Number.
Qualification for Small Business Fees
Beginning FY 2004 (October 1, 2003), firms with annual gross sales
and revenues with $30 million or less, including gross sales and
revenues of all affiliates, partners, and parent firms, may qualify
for lower rates for Premarket Notification 510(k) submissions. Please
note that affliliate is defined by §737(8) of the FD&C
Act: An affiliate means a business entity that has a relationship
with a second business entity if, directly or indirectly,
one business entity controls, or has the power to control, the
other business entity; or
a third party controls, or has power to control, both of the
business entities.
To qualify for FY 2004, the firm is required to submit the FY 2004
MDUFMA Small Business Qualification Certification (Form FDA 3602).
In addition, certified copies of the firm's Federal Income Tax Return
for the most recent taxable year, including certified copies of
the income tax returns of all affiliates, partners, and parent firms
must be provided.
The following guidance and form should be used.
FY2004 MDUFMA Small Business Qualification Worksheet and Certification
http://www.fda.gov/cdrh/mdufma/guidance/1225.pdf.
FY 2004 MDUFMA Small Business Qualification Certification (Form
FDA 3602) is provided as an attachment to this guidance.
FY2005 MDUFMA Small Business Qualification Worksheet and Certification
http://www.fda.gov/cdrh/mdufma/guidance/2005.pdf.
FY 2004 MDUFMA Small Business Qualification Certification (Form
FDA 3602) is provided as an attachment to this guidance.
The Certification should be sent to:
MDUFMA Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International and Consumer
Assistance
1350 Piccard Dr.
Rockville, MD 20850
FDA will review the Certification within 60 days and send its decision
that the firm is, or is not, a small business eligible for reduced
or waived fees. If the firm qualifies as a small business, the decision
letter will include a Small Busines Decision number. The Small Business
Decision number is used on the Medical Device User Fee Cover Sheet
(Form FDA 3601) to demonstrate that the firm is entitled to a reduced
fee. If a firm submits a reduced fee to FDA without a Small Business
Decision number, the submission will not be accepted for filing.
The small business status expires at the end of each fiscal year
(September 30th). A new MDUFMA Small Business Qualification Certification
must be submitted each year to qualify as a small business.
Additional information on medical device user fees is available
at http://www.fda.gov/cdrh/mdufma/.
Please note that FDA policy on issues related to medical device
user fees is still under development. FDA will post policy issues
with respect to user fees on the user fee website as it becomes
available.
